MAUDE Adverse Event Report: ARTHREX, INC. IMPLSYS 2NDRY FIXATN PEEKSWVLK 4.75X19.1; NON-DEGRADABLE FIXATN FASTENER

Model Number	IMPLSYS 2NDRY FIXATN PEEKSWVLK 4.75X19.1
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 12/30/2022, it was reported by a sales representative via sems that an ar-1588btb-2j tightrope ii btb suture was bunched up and unable to pass through the button.Then, while attempting to use an ar-1593-p peek swivelock, the eyelet of the anchor snapped off when the surgeon passed the suture through it using a flag.This was discovered on the back table while prepping the graft during an aclr procedure on (b)(6) 2022.Case was completed using a new ar-1588btb-2j tightrope ii btb and an ar-1593-p peek swivelock.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.  arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The complaint device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure can be attributed to user-applied excessive mechanical forces.

• Brand Name: IMPLSYS 2NDRY FIXATN PEEKSWVLK 4.75X19.1
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 19448663
• Report Number: 1220246-2024-04734
• Device Sequence Number: 18329747
• Product Code: MBI
• UDI-Device Identifier: 00888867331303
• UDI-Public: 00888867331303
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K151342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IMPLSYS 2NDRY FIXATN PEEKSWVLK 4.75X19.1
• Device Catalogue Number: AR-1593-P
• Device Lot Number: 15024108
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2022
• Initial Report FDA Received Date: 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown